Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01395472
First received: July 13, 2011
Last updated: July 27, 2011
Last verified: April 2011
  Purpose

The aim of this study is to determine the effects of an acute session of physical exercise on cognitive functioning and humor of traumatic brain injury patients and to investigate whether different cognitive responses can be achieved with different intensities of exercise (moderate and vigorous).

The investigators hypothesize that while moderate intensity physical exercise may be beneficial to cognitive functioning, vigorous intensity may be detrimental to TBI patients, as physical fatigue may impair alertness and other higher cognitive functions.


Condition Intervention
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Behavioral: Acute Physical Exercise
Behavioral: Stretching protocol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Neuropsychological evaluation [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    Neuropsychological evaluation will be held immediately before the execution of physical exercise (maximal, 30 minutes in ventilatory threshold I or stretching exercise) and immediately after the conclusion of exercise.


Secondary Outcome Measures:
  • Mood, fatigue and impulsivity questionnaires [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Mood, fatigue and impulsivity questionnaires will be held immediately before the execution of physical exercise (maximal, 30 minutes in ventilatory threshold I or stretching exercise) and immediately after the conclusion of exercise


Estimated Enrollment: 36
Study Start Date: January 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TBI - Experimental Sample
TBI patients will be submitted to two acute physical exercise protocols in a cycloergometer with one weak of interval (until voluntary exhaustion and 30 minutes in ventilatory threshold I)
Behavioral: Acute Physical Exercise
Patients and healthy volunteers will be submitted to a protocol of progressive maximal exercise until voluntary exhaustion and one weak later to 30 minutes of physical exercise in ventilatory threshold I, both in the same cycloergometer.
Active Comparator: Healthy Controls
healthy volunteers will be submitted to two acute physical exercise protocols in a cycloergometer with one weak of interval (until voluntary exhaustion and 30 minutes in ventilatory threshold I)
Behavioral: Acute Physical Exercise
Patients and healthy volunteers will be submitted to a protocol of progressive maximal exercise until voluntary exhaustion and one weak later to 30 minutes of physical exercise in ventilatory threshold I, both in the same cycloergometer.
Active Comparator: TBI Controls
Patients will be submitted to a protocol of stretching for 30 minutes
Behavioral: Stretching protocol
TBI patients will be submitted to 30 minutes of stretching exercises composed of 15 exercises that prioritize back, legs and hip.

Detailed Description:

It is well known the benefits of physical exercise to cognitive functioning, which have been demonstrated in animal studies and in those with healthy humans or with individuals with some type of pathology. Nevertheless, there are few studies investigating the effects of acute physical exercise on cognitive functions of people with traumatic brain injury, even though they frequently have impairments in several cognitive domains due to their brain damage.

The effect of two intensities of physical exercise (moderate and exhaustive) in attention, processing speed, memory, executive control and decision making will be investigated in patients with TBI. For that matter, their performance will be compared to non-brain injured subjects submitted to the same protocol and to TBI patients submitted to a stretching session.

Each subject will be submitted to a neuropsychological evaluation before and after the physical exercise in order to determine if there is an improvement in cognitive performance post-exercise.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Patients with TBI eligible for participation in this research study must meet the following inclusion criteria:

Inclusion Criteria:

  • diagnose of moderate to severe TBI
  • be at least six-months post-injury
  • have a neurologist that allowed to enroll into the study
  • be able to take part in a cycloergometer-protocol, attested by the laboratory (CEPE) physician
  • brain injury must have occurred in adult life
  • provided written informed consent for participation

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395472

Contacts
Contact: Patricia Rzezak, PhD (5511)5572-0177 patriciarzezak@gmail.com

Locations
Brazil
Centro de Estudos em Psicobiologia e Exercício/AFIP Recruiting
Sao Paulo, SP, Brazil, 04020-050
Principal Investigator: Patricia Rzezak, PhD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Marco T De Mello, PhD Centro de Estudos em Psicobiologia e Exercício/AFIP
Principal Investigator: Patricia Rzezak, PhD Centro de Estudos em Psicobiologia e Exercício/AFIP
  More Information

No publications provided

Responsible Party: Patricia Rzezak PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01395472     History of Changes
Other Study ID Numbers: TBI-1858/09
Study First Received: July 13, 2011
Last Updated: July 27, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
TBI
Acute physical exercise
Cognitive functions
Mood

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Wounds and Injuries
Brain Injuries
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2014